Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations

Phase 2 Unknown 14 enrolled Academic and Community Cancer Research United National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Pemigatinib may stop the growth of tumor cells by blocking FGFR, which is needed for cell growth.

Timeline

Start: 2020-08-31
Primary completion: 2022-05-13
Completion: 2025-12-01

Outcome

Missed primary endpoint

paper the objective response rate as well as clinical benefit rate were 0%. PMID 40515475 ↗

Publications

Wheless MC, Zemla TJ, Hubbard JM, Strickler JH, Gbolahan OB, Wilson L, Waechter B, Ou FS, Nixon AB, Bekaii-Saab TS, Ciombor KK. A phase II, multicenter, single-arm study of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring FGFR alterations. Oncologist. 2025 Jun 4;30(6):oyaf069. doi: 10.1093/oncolo/oyaf069.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pemigatinib	Small molecule	—	Oral